EXCLUSIVE DISTRIBUTION AGREEMENT

EXHIBIT 10.4

EXCLUSIVE DISTRIBUTION AGREEMENT

     THIS EXCLUSIVE DISTRIBUTION AGREEMENT (this “ Agreement ”) is made as of January 13, 2009 (the “ Effective Date ”), by and between NuVasive, Inc., a corporation organized under the laws of the State of Delaware, U.S.A., with an address at 7473 Lusk Boulevard, San Diego, California 92121 (“ NuVasive ”), and Progentix Orthobiology B.V., a corporation organized under the laws of Holland, with an address at Professor Bronkhorstlaan 10, building 48, 3723 MB Bilthoven, The Netherlands (“ Progentix ”).

RECITALS

     NuVasive entered into that certain Preferred Stock Purchase Agreement (the “ Preferred Stock Purchase Agreement ”) with Progentix and the shareholders of Progentix (the “ Progentix Shareholders ”) of even date herewith pursuant to which NuVasive purchased shares of Progentix from the Progentix Shareholders representing, immediately after such issuance, forty percent (40%) of the outstanding capital stock of Progentix on a fully-diluted basis.

     NuVasive entered into that certain Option Purchase Agreement (the “ Option Purchase Agreement ”) with Progentix and the Progentix Shareholders of even date herewith pursuant to which, and subject to certain exceptions set forth therein, (i) NuVasive may elect, in its sole discretion, to cause the Progentix Shareholders to sell to NuVasive all of their issued and outstanding shares of the capital stock of Progentix upon delivery of a Purchase Election Notice (as defined therein) to the Company (the “ Call Option ”) at any time between the second anniversary of the Option Purchase Agreement and the fourth anniversary of the Option Purchase Agreement (the “ Call Option Period ”), and (ii) NuVasive shall be obligated to purchase from the Progentix Shareholders all of the shares of capital stock of Progentix held by the Shareholders in the event (A) the Progentix Shareholders (or the Shareholder Representative) delivers a Milestone Completion Notice (as defined therein) to NuVasive (the “ Put Option ”) at any time between the date of the Option Purchase Agreement and the second anniversary of the Option Purchase Agreement (the “ Put Option Period ”), or (B) the Progentix Shareholders (or the Shareholder Representative) delivers a Second Put Option Notice (as defined therein) to Nuvasive (the “ Second Put Option ”) at any time between the second anniversary of the Option Purchase Agreement and the fourth anniversary of the Option Purchase Agreement. The period from the date of the Option Purchase Agreement through the expiration of the Call Option Period shall be referred to herein as the “ Option Period .”

     In connection with the Option Purchase Agreement, Progentix desires to appoint NuVasive as its exclusive distributor for the products described on Exhibit A (the “ Products ”) pursuant to the terms and conditions contained herein.

AGREEMENT

The parties, intending to be legally bound, agree as follows:

1. APPOINTMENT; LICENSE.

     1.1 Appointment . Progentix hereby appoints NuVasive, for the term of this Agreement, as its exclusive, worldwide distributor of the Products for all indications and applications other than the Retained Field (the “ Field ”). NuVasive hereby accepts such appointment. As used herein, “exclusive” shall mean that Progentix shall not itself promote, market or sell the Products anywhere in the world (other than as set forth in Section 1.2 below) and shall not appoint any other agents, representatives or distributors to promote, market or sell the Products (other than as set forth in Section 1.2 below) anywhere in the world. NuVasive shall have the right to appoint sub-distributors as it determines in its sole discretion.

     1.2 Retained Rights . Progentix shall retain for itself and/or its designee and/or licensee the right to promote, market and sell Products into the Retained Field (as defined below), but excluding sales to hospitals or other surgical centers. For clarity, Progentix may subcontract the right to manufacture Products to a third party. As used herein, “ Retained Field ” shall mean dental and craniomaxillofacial applications. For clarity, NuVasive shall not have the right to promote, market and sell Products into the Retained Field.

     1.3 Product Discontinuance . Progentix shall not discontinue the supply of any or all Products in the Field or make any material changes to any Products manufactured hereunder without the prior written consent of NuVasive.

     1.4 Independent Purchaser Status . NuVasive is an independent purchaser and seller of the Products. Neither party shall act as an agent or legal representative of the other party. Neither party shall have the right or power to act for or bind the other party in any respect or to pledge its credit. NuVasive shall be free to resell the Products on such terms as it may, in its sole discretion, determine, including, without limitation, price, returns, credits and discounts. NuVasive shall be responsible for all of its own expenses with respect to the promotion, marketing, distribution and sales of Product. The detailed operations of NuVasive under this Agreement are subject to the sole control and management of NuVasive.

2. PROMOTIONAL; REGISTRATIONS.

     2.1 Promotional Materials . Promptly following the Effective Date, and as and when Progentix generates new promotional material, Progentix shall provide to NuVasive samples of all such advertising and promotional literature and documentation produced by or for Progentix for the Products, if any. NuVasive shall have the right to reproduce, prepare translations, use and distribute such literature and documentation in connection with its activities under this Agreement.

     2.2 Registrations . At its own expense, Progentix shall diligently seek to obtain from the regulatory authorities in major markets as mutually agreed in good faith (which will include without limitation the U.S. Food and Drug Administration (“ FDA ”) and European Medicines Agency (“ EMEA ”)) all registrations, licenses, permits and/or approvals required by such regulatory authorities for the promotion, marketing and sale of Products in the Field (collectively, “ Registrations ”). Progentix shall keep NuVasive informed of the status of the Registrations and shall consult with NuVasive regarding any responses or other actions by Progentix regarding the Registrations. After the second (2nd) anniversary of the Effective Date, NuVasive shall have the right upon written notice to Progentix to assume control over the

process of acquiring the Registrations, provided that NuVasive shall be responsible for its own expenses related thereto and further provided that NuVasive shall cooperate and consult in good faith with Progentix in connection therewith. In any such event, Progentix and its personnel, at NuVasive’s expense, shall cooperate with NuVasive in obtaining the Registrations. Upon the earlier of the expiration or termination of this Agreement, Progentix shall again assume control over the process of acquiring the Registrations. In any such event, NuVasive and its personnel shall cooperate with Progentix in transferring such control back to Progentix.

     2.3 Intellectual Property Prosecution . At its own expense, Progentix shall control the preparation, filing, prosecution, maintenance and enforcement of patents and other intellectual property rights relating to the Products, and shall seek to obtain all such available rights in a diligent and commercially reasonable manner. After the second (2nd) anniversary of the Effective Date, NuVasive shall have the right upon written notice to Progentix to exclusively control the preparation, filing, prosecution, maintenance and enforcement of patents and other intellectual property rights relating to the Products in the Field; provided that NuVasive shall be responsible for its own expenses related thereto and further provided that NuVasive shall cooperate and consult in good faith with Progentix in connection therewith. In any such event, Progentix and its personnel, at Progentix’s expense, shall cooperate with NuVasive, execute all lawful papers and instruments and make all rightful oaths and declarations as may be necessary in the preparation, filing, prosecution, maintenance and enforcement of all patents and other intellectual property rights relating to the Products in the Field. Upon the earlier of the expiration or termination of this Agreement, Progentix shall again assume exclusive control the preparation, filing, prosecution, maintenance and enforcement of patents and other intellectual property rights relating to the Products in the Field. In any such event, NuVasive and its personnel shall cooperate with Progentix in transferring such exclusive control back to Progentix.

     2.4 Trademark . NuVasive shall have the right to use any of Progentix’s trademarks in connection with the promotion, marketing, distribution and sale of the Products in the Field. Upon reasonable request, NuVasive will provide Progentix with samples of any proposed and/or actual use, quality and style of the Progentix’s trademarks. NuVasive will strictly comply with all standards with respect to Progentix’s trademarks which may be furnished by Progentix from time to time, and all uses of Progentix’s trademarks in proximity to the trade name, trademark, service name or service mark of any third party will be consistent with the standards furnished by Progentix to NuVasive from time to time. NuVasive will not engage, participate or otherwise become involved in any activity or course of action that diminishes, tarnishes or otherwise adversely affects the goodwill associated with any Progentix trademark. If Progentix determines that NuVasive is using or displaying any of Progentix’s trademarks in a manner that is or may be detrimental to Progentix’s interest, Progentix may issue reasonable instructions to NuVasive concerning the manner, if any in which NuVasive may continue to use such trademarks. NuVasive shall promptly comply with such instructions or cease the use or display of such trademarks. Any goodwill associated with any Progentix trade marks affixed or applied or used in relation to the Products shall accrue to the sole benefit of Progentix.

     2.5 Product Recalls . In the case of a Product recall or other corrective field action other than a Product recall or corrective field action to the extent resulting from NuVasive’s

negligence or breach of this Agreement, the parties shall work together and NuVasive shall promptly implement such Product recall or corrective field action at Progentix’s expense.

3. TERMS AND CONDITIONS OF SALE.

     3.1 Rolling Forecasts . Except as set forth in Section 3.2 below, not later than thirty (30) days prior to the beginning of each calendar quarter during the term of this Agreement, NuVasive shall prepare and provide Progentix with a twelve (12) month rolling forecast of its good faith estimated purchase requirements for each of the Products (the “ Rolling Forecast ”). The quantity of the Products specified in the Rolling Forecast for the first three (3) month period reflected therein shall be a binding obligation of NuVasive to purchase, and a binding obligation of Progentix to supply, the forecasted quantity. The remainder of the Rolling Forecast shall be non-binding, and for planning purposes only. Progentix shall have no obligation to supply above one hundred fifty percent (150%) of the quantity of Products specified in the first three (3) month period of the Rolling Forecast, but if requested by NuVasive, Progentix shall exercise commercially reasonable efforts to deliver up to one hundred fifty percent (150%), of the quantity of Products specified in the first three (3) month period of the Rolling Forecast. For each of the fourth through twelfth months in each Rolling Forecast, although the quantities forecast may exceed one hundred twenty-five percent (125%) of the amount forecast for such month in the previous Rolling Forecast, the supply obligations of Progentix shall not exceed one hundred twenty-five percent (125%) of the amount forecast for such month in the previous Rolling Forecast; provided that, if requested by NuVasive, Progentix shall exercise commercially reasonable efforts to supply such excess.

     3.2 Limitations . Notwithstanding anything in this Agreement to the contrary, in no event shall Progentix be required to supply more than (i) *** cubic centimeters of the Granules Product during the first six months of this Agreement and in any event with delivery prior to the end of the sixth month of this Agreement, (ii) more than *** cubic centimeters of the Granules Product over any two (2) month period during the seventh through twelfth months of this Agreement or (iii) a total of *** cubic centimeters of the Granules Product over the first twelve (12) months of this Agreement. Notwithstanding anything in this Agreement to the contrary, the parties shall mutually agree upon product specifications and initial supply and purchase obligations with respect to the Putty Product and the Block Product.

     3.3 Shipping . Progentix shall ship Products to NuVasive in accordance with the times set forth in NuVasive’s purchase order (or binding portion of the Rolling Forecast, as applicable). The Products shall be delivered FCA Progentix manufacturing facility (Incoterms 2000). Risk of loss shall pass to NuVasive upon delivery by Progentix to NuVasive’s designated carrier. NuVasive shall be responsible to pay all carrier costs, shipping and handling charges.

     3.4 Disposables . If any of the Products are disposable or perishable, Progentix shall provide such Products with shelf life of no less than two (2) years on the date of the shipment to NuVasive.

     3.5 Non-Conforming Product . NuVasive shall send to Progentix a notice regarding any Product that deviates or otherwise fails to comply with the warranties described in Section 5 (each a “ Defect ” and/or “ Defective ”) or shortages with respect to any shipment of Products (a “ Deficiency Notice ”) within thirty (30) calendar days after receipt of the Products. If a Defect in the Products could not reasonably be discovered within this thirty (30) calendar day period (a “ Latent Defect ”), then NuVasive shall have the right to reject such Products within ten (10) calendar days after discovering the Latent Defect. Progentix shall either request NuVasive to return or destroy such Defective Product (in each case, at Progentix’s expense) and shall promptly furnish to NuVasive replacement Products that are not Defective. Subject to the provisions of this Section, NuVasive has the right to reject and return, at the expense of Progentix and for full credit, any Defective portion of any shipment, without invalidating the remainder of the order.

     3.6 Capacity . At all times during the term of this Agreement, Progentix shall maintain sufficient capacity to meet NuVasive’s forecasted requirements with respect to the Products. Notwithstanding the foregoing, Progentix shall not be required to maintain such capacity in the event such capacity would reasonably require the purchase of additional manufacturing equipment or the incurrence of related manufacturing expenses and NuVasive shall not approve such expenditures ( i.e. , pursuant to the terms of the Preferred Stock Purchase Agreement, Option Purchase Agreement or any other agreement contemplated thereunder).

4. PRICE AND PAYMENT.

     4.1 Price . Prices payable by NuVasive for the Products shall be as follows. The price for each Product shall be calculated promptly following the beginning of each calendar quarter by determining NuVasive’s “ Average Gross Sales Price ” for such Product during the immediately prior calendar quarter and multiplying such price by the “ Sales Percentage ” as determined in Section 4.2. In the event the Product is sold on a stand-alone basis, “ Average Gross Sales Price ” shall mean *** . The price for each Product during the initial calendar quarter shall be determined in good faith by the parties based on the estimate of the applicable selling price and using the above formula with such estimated gross sales price. Notwithstanding the foregoing, the price for the Granule Product shall initially be set at *** per cubic centimetre and shall never be less than *** per cubic centimetre. In the event the Product is sold in combination with one or more other products or components (a “ Combination Product ”), then “ Average Gross Sales Price” shall be calculated as set forth above, multiplied by a proration factor that is determined as follows: *** .

     4.2 Sales Percentage . Commencing on the Effective Date and continuing until the second (2nd) anniversary of the Effective Date, the Sales Percentage shall be *** percent (***%). After the second (2nd) anniversary of the Effective Date and until the fourth (4th) anniversary of the Effective Date, the Sales Percentage shall be *** percent (***%). Following the fourth (4th) anniversary of the Effective Date, the Sales Percentage shall be *** percent (***%). Notwithstanding the foregoing, if Progentix delivers to NuVasive a Milestone Completion Notice (as defined in the Option Purchase Agreement), triggering the Put Option and NuVasive does not consummate the Acquisition (as defined in the Option Purchase Agreement)